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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device enzymatic esterase--oxidase, cholesterol
Regulation Description Cholesterol (total) test system.
Product CodeCHH
Regulation Number 862.1175
Device Class 1


Premarket Reviews
ManufacturerDecision
ABBOTT IRELAND DIAGNOSTICS DIVISION
  SUBSTANTIALLY EQUIVALENT 1
MEDICON HELLAS S.A
  SUBSTANTIALLY EQUIVALENT 1
  1.  K232404  CHOLESTEROL; HDL-cholesterol ; LDL-cholesterol; TR ...
TRUVIAN HEALTH
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 2 2
2022 4 4
2023 4 4
2024 8 8
2025 14 14
2026 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 11 11
Non Reproducible Results 10 10
High Test Results 8 8
Low Test Results 7 7
Material Integrity Problem 2 2
Circuit Failure 1 1
Display Difficult to Read 1 1
Incorrect Measurement 1 1
No Device Output 1 1
Chemical Problem 1 1
Erratic Results 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 33 33
Insufficient Information 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Beckman Coulter Inc. II Dec-20-2021
2 Randox Laboratories Ltd. II Jul-20-2022
3 Randox Laboratories Ltd. II Dec-01-2021
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